Department of Health and Human Services December 20, 2005 – Federal Register Recent Federal Regulation Documents
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Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices)
The Food and Drug Administration (FDA) is announcing the following public meeting: Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices). The topics of discussion are the agency's activities regarding the regulation and approval of circulatory support devices used for temporary support in pediatric patients. Date and Time: The public meeting will be held on January 20, 2006, from 9 a.m. to 12 p.m. The agency is requiring registration by December 30, 2005. Location: The public meeting will be held at the Center for Devices and Radiological Health, rm. 20B, 9200 Corporate Blvd., Rockville, MD 20850. Contact: Eric Chen, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 301-443- 8262, ext. 146, e-mail: eac@cdrh.fda.gov, or Michael Berman (HFZ-170), 12725 Twinbrook Pkwy., 301-827-4744, e-mail: mrb@cdrh.fda.gov. If you need special accommodations due to a disability, please contact Eric Chen, at least 7 days in advance of the meeting. Registration: There is no fee to attend the workshop; however, because space is limited, registration is required. Please submit registration information (including name, title, firm name, address, e- mail address, telephone number, and fax number) by December 30, 2005 (see Contact). Background information for the workshop will be available to the public on the Internet at https://www.fda.gov/cdrh/ meetings/012006workshop/.
New Animal Drugs; Change of Sponsor; Chloramphenicol Capsules
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for chloramphenicol capsules from Nylos Trading Co., Inc., to Pharmaceutical Ventures, Ltd.
Notice of Approval of Supplemental New Animal Drug Application; Tilmicosin
The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The approved NADA provides for the veterinary prescription use of an injectable solution of tilmicosin phosphate for respiratory disease in cattle and sheep. This supplemental NADA adds user safety information to product labeling.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
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